Trial · NCT02653391
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and Severity of Ocular TEAEs. | Screening Visit, Baseline (Day 1), Week 1, Week 4, Week 8, Week 12, and Week 16 | The incidence and severity of ocular treatment emergent adverse events (TEAEs) |
| Primary | The Incidence and Severity of Systemic Adverse Events | Screening Visit, Baseline (Day 1), Week 1, Week 4, Week 8, Week 12, and Week 16 | The incidence and severity of systemic treatment emergent adverse events (TEAEs) |
| Primary | Change From Baseline in Findings From Slit Lamp Examinations (SLE) Part A | Baseline, Week 1, Week 4, Week 8, Week 12, and Week 16 | Number of participants who had a change from baseline from normal or abnormal not clinically significant, to abnormal clinically significant (CS) findings for slit lamp examinations (SLE) for Part A. Part B is reported as separate outcome since unit of measure is number of eyes. |
| Primary | Change From Baseline in Findings From Slit Lamp Examinations (SLE) Part B | Baseline, Week 1, Week 4, Week 8, Week 12, and Week 16 | Number of eyes with a change from baseline from normal or abnormal not clinically significant, to abnormal clinically significant (CS) findings for slit lamp examinations (SLE) for Part B. Part A is reported as separate outcome. |
| Primary | Change From Baseline in Intraocular Pressure (IOP) for Part A | Baseline, Week 1, Week 4, Week 8, Week 12 | Change from Baseline in intraocular pressure (IOP) using Goldmann applanation tonometry for Part A |
| Primary | Change From Baseline in Intraocular Pressure (IOP) for Part B | Baseline, Week 1, Week 4, Week 8, Week 12 , and Week 16 or early discontinuation visit | Change from Baseline in intraocular pressure (IOP) using Goldmann applanation tonometry for Part B. Part A is reported separately. |
| Secondary | Change From Baseline in Central Corneal Thickness by Visit Part A as Measured by Pachymetry for Part A | Baseline, Week 1, Week 4, Week 8, Week 12, and Week 16 | Change from Baseline in Central Corneal Thickness by Visit as measured by Pachymetry for Part A. Part B is reported as a separate outcome measure. |
| Secondary | Central Corneal Thickness Part B | Baseline (Day 1), Week 1, Week 4, Week 8, Week 12, and Week 16, or Early discontinuation visit | Central Corneal Thickness: by-subject data as measured by Pachymetry and Pentacam. Part A is reported as a separate outcome measure. |
| Secondary | Change From Baseline Endothelial Cell Hexagonality in Percentage Over All 12 Weeks for Part A | Baseline, Week 1, 4, 8, and 12 | Change From Baseline in Endothelial Cell Hexagonality in Percentage Over All 12 Weeks for Part A. Specular microscopy is a noninvasive photographic technique that allows visualization and analyzation the corneal endothelium. Using computer-assisted morphometry, specular microscopes analyzes the size, shape and population of the endothelial cells. Histologically, healthy corneal cells initially have a hexagonal shape. As endothelial cells die, neighboring cells enlarge to cover the empty space once occupied by the cell. This, in turn, causes the remaining cells to lose their hexagonal shape. Assessments were performed using the flex center and full auto methods for Part A and data from the flex center method was summarized. The flex center method was used for Part B. The percent of Part B is entered as a separate outcome measure. A decrease from baseline in % cell hexagonality means worse outcome, a increase from baseline means better outcome. |
| Secondary | Corneal Endothelial Cell Hexagonality Part B | Baseline, Week 1, Week 4, Week 8, Week 12, and Week 16 or early discontinuation visit | Corneal Endothelial Cell Hexagonality in Percentage by-subject data: Part B. Data was only listed in weeks where images were good enough quality to quantify. Specular microscopy is a noninvasive photographic technique that allows visualization and analyzation the corneal endothelium. Using computer-assisted morphometry, specular microscopes analyzes the size, shape and population of the endothelial cells. Histologically, healthy corneal cells initially have a hexagonal shape. As endothelial cells die, neighboring cells enlarge to cover the empty space once occupied by the cell. This, in turn, causes the remaining cells to lose their hexagonal shape. The flex center method was used for Part B. A decrease in percent of cell hexagonality from baseline means worse outcome, an increase from baseline means better outcome. |
| Secondary | Change From Baseline in Best Corrected Visual Acuity (BCVA) Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale for Part A. | Baseline, Weeks 1, 4, 8, 12, and 16 | Best corrected visual acuity (BCVA) using the using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale by visit. ETDRS charts present a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows; there is a total of 14 lines (70 letters), with letter size increasing further geometrically and equivalently in every line by a factor of 1.2589 (or 0.1 log unit), moving up the chart. Minimum score of zero, maximum score of 100. Change from baseline: a more negative score is worse outcome, a more positive score is better outcome. A lower score means less letters were read correctly (worse outcome) and a higher score means more letters were read correctly (better outcome). Part B was listed separately. |
| Secondary | Best Corrected Visual Acuity (BCVA) Score Using ETDRS Scale for Part B | Baseline, Weeks 1, 4, 8, 12, and 16 | Best corrected visual acuity (BCVA) using the using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale by visit. ETDRS charts present a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows; there is a total of 14 lines (70 letters), with letter size increasing further geometrically and equivalently in every line by a factor of 1.2589 (or 0.1 log unit), moving up the chart. Minimum score of zero, maximum score of 100. Change from baseline: a more negative score is worse outcome, a more positive score is better outcome. A lower score means less letters were read correctly (worse outcome) and a higher score means more letters were read correctly (better outcome). |
| Secondary | Change From Baseline in Endothelial Cell Density Over All 12 Weeks for Part A | Baseline, Weeks 1, 4, 8, and 12 | Change From Baseline in Endothelial Cell Counts, or density (Counts/mm\^2) over all 12 weeks for Part A. Part B is entered as a separate outcome measure. |
| Secondary | Corneal Endothelial Cell Density Part B | Baseline, Weeks 1, 4, 8, 12, and 16. | Corneal Endothelial Cell Density: Part B, By-subject data for all time points where images were readable. For all time points where there were "Poor Quality Images" or "too few cells to register", there were no data available, and these were not listed below. |
| Secondary | Change From Baseline in Endothelial Cell Coefficient of Variation Over All 12 Weeks for Part A | Baseline, Week 12 | Change From Baseline in Endothelial Cell Coefficient of Variation Over All 12 Weeks. Coefficient of variation (CV) is Standard deviation (SD) of cell area divided by the mean cell area of endothelial cell analyzed. CV represents the coefficient, or degree, of variation in the sizes of the endothelial cells (polymegethism). By measuring the variation in size between endothelial cells, the system can measure how much cell loss is occurring. The more variation, the worse the outcome. Part B is is entered as a separate outcome measure. |
| Secondary | Coefficient of Variation (CoV) Part B | Baseline, Weeks 1, 4, 8,12, and 16 | Part B, By-subject data for all time points where images were readable. For all time points where there were "Poor Quality Images" or "too few cells to register" there were no data available. CoV represents the coefficient, or degree, of variation in the sizes of the endothelial cells. By measuring the variation in size between endothelial cells, the system can measure how much cell loss is occurring. A CoV less than 40 is normal. |
| Secondary | Change From Baseline in Corneal Area Affected by Microcysts for Part A | Baseline, Weeks 1, 4, 8, 12, and 16 | Change from Baseline in corneal area affected by microcysts by visit for Part A. |
| Secondary | Corneal Area Affected by Microcysts: Part B | Baseline, Weeks 1, 4, 8, 12, and 16, or early discontinuation visit | Corneal area affected by microcysts: by-subject data for Part B. No microcysts were present for any timepoints. |
| Secondary | Change From Baseline in Corneal Bullae for Part A. | Baseline, Week 1, Week 4, Week 8, Week 12, Week 16 | Count of participants in number, size and location of bullae by treatment. Part B is listed separately. |
| Secondary | Corneal Bullae: Part B | Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, or early discontinuation visit | Number, size and location of Corneal bullae: By-subject data: Part B. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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